Smart Pack System for Medicines

ABSTRACT

Disclosed is a blister pack smart dispensing package that has an overlay with conductors located over blister pack pockets that are broken when a user retrieves a solid medication, such as a pill, from the blister pack. The date and time that the user retrieved the solid medication from the smart pack is recorded by an electronics and communications package on the smart pack. A local communications device then receives this adherence data and transmits this data to a server, which generates a data structure containing adherence data. A blister pack overlay can be used which changes colors to indicate that the medication is about to expire, or has expired.

CROSS REFERENCE TO RELATED APPLICATIONS

This Application is a continuation application of U.S. patentapplication Ser. No. 15/621,842, filed on Jun. 13, 2017, now U.S. Pat.No. ______; which in turn claims priority to U.S. ProvisionalApplication No. 62/351,954, filed on Jun. 18, 2016. Each of theforegoing applications is incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION

Medicines have played an important role in the health and welfare ofpeople throughout the world. Medicines have cured diseases, preventedinfections from spreading, and reduced the instances of serious healthproblems. Prescription pharmaceuticals have been especially important inpreventing, treating, and curing diseases.

SUMMARY

An embodiment of the present invention may therefore comprise a packetfor dispensing solid medications comprising: a blister pack having aplurality of blister pockets that contain said medication; an overlaythat is attached to said blister pack; geometric pattern conductorsdisposed on said overlay and aligned with said blister pockets when thatoverlay is attached to said blister pack so that said geometric patternconductors are broken when said medication is removed from said blisterpockets creating open circuits in said geometric pattern conductors; aplurality of connecting conductors disposed on said overlay that areconnected to said geometric pattern conductors in a manner that providessufficient information to detect said open circuits in said geometricpattern conductors and identify said geometric pattern conductors thathave been broken; processing and storage circuitry disposed on saidplastic overlay that detect said open circuits and store a time whensaid open circuit is detected, to create adherence data.

An embodiment of the present invention may further comprise a method ofpackaging solid medication in a packet and collecting adherence dataindicating patient adherence to a medication schedule comprising:filling blister pockets in a blister pack with said solid medication;placing geometric pattern conductors on an overlay that are aligned withsaid blister pockets when said overlay is attached to said blister pack;placing a plurality of connecting conductors on said overlay that areconnected to said geometric pattern conductors so that said geometricpattern conductors that have been broken can be identified; placing saidoverlay on said blister pack, said overlay having electronics andcommunication circuitry; and using said electronics and communicationcircuitry to detect when said geometric pattern conductors are broken bychecking conductance of said connecting inductors; storing a time anddate when said geometric pattern conductors are broken, to create saidadherence data.

An embodiment of the present invention may further comprise an automateddispenser that dispenses medications to a user comprising: a packagecontaining medications comprising: a blister package containing saidmedication in blister pockets; processing, storage, and communicationcircuitry disposed on an overlay that covers said blister pockets, saidprocessing storage, and communication circuitry containing identifyingsaid medication; communication electronics disposed in said automateddispenser that receives prescriptions for said medication and receivessaid data identifying said medication from said processing, storage andcommunication circuitry disposed on said overlay; a processor thatgenerates control signals that control a card reader that reads debitand credit cards, a display screen to prompt said user, a labeler thatgenerates a label containing information identifying a patient takingsaid medication and instructions for taking said medication, and adispenser that dispenses said medication.

An embodiment of the present invention may further comprise a method ofautomatically dispensing medication to an authorized user of anautomated dispenser comprising: packaging said medication in a blisterpackage having processing, storage and communication circuitry disposedon an overlay of said blister package that contains data that identifiessaid medication packaged in said blister package; communicating saiddata identifying said medication from said blister package to saidautomated dispenser; receiving prescription data for a patient at saidautomated dispenser; programming said blister package with saidprescription data; generating a patient label identifying said patientfor said medication and instructions for use of said medication;applying said patient label to said blister package; verifying that auser of said automated dispenser is said authorization user of saidautomated dispenser; dispensing said medication to said authorized user.

An embodiment of the present invention may further comprise acommunication system that communicates adherence data, indicatingadherence by a patient to a medication schedule, for access byauthorized individuals on a network comprising: a smart dispensingpackage comprising: a blister pack having a plurality of blister pocketsthat contain medication; a plastic overlay that is attached to saidblister pack; a plurality of geometric pattern conductors disposed onsaid plastic overlay that are aligned with said blister pockets whensaid overlay is attached to said blister pack do that said geometricpattern conductors are broken when said medication is removed from saidblister pockets, creating an open circuit; a plurality of connectingconductors disposed on said overlay that are connected to said geometricpattern conductors in a manner that provides sufficient information todetect an open circuit in each of said geometric pattern conductors sothat open circuits in each of said geometric pattern conducts can beidentified; processing and storage circuitry disposed in said plasticoverlay that detects said open circuits and stores a time when said opencircuit is detected, to create adherence data; communication circuitrydisposed on said plastic overlay and connected to said processing andstorage circuitry that transmits said adherence data on an antennadisposed in said plastic overlay; a handheld communicator that receivessaid adherence data from said smart dispensing package and transmitssaid adherence data to a network for storage and access by saidauthorized individuals.

An embodiment of the present invention may further comprise a method oftransmitting adherence data from a packet that contains solidmedications comprising: packaging said medication in blister pockets ofa blister package; detecting an opening of a blister pocket by detectingconductance of a plurality of conductors disposed on an overlay thatcover said blister pockets; recording a time when said blister pocket isopened to create adherence data; transmitting said adherence data fromsaid packet to a handheld communicator; transmitting said adherence datafrom said handheld communicator to a network that is accessible byauthorized individuals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram of an embodiment of a blister packsmart dispensing package (smart pack).

FIG. 2 is a detailed view of an embodiment of a smart dispensingpackage.

FIG. 3 is a schematic block diagram of the data transfer structure forthe smart pack system.

FIG. 4 is a flow diagram of the distribution and data collection processfor an embodiment of a smart pack system.

FIG. 5 is an illustration of an embodiment of a smart pack package forthe smart pack system.

FIG. 6 is a schematic illustration of an embodiment of an automatedsmart pack dispenser.

FIG. 7 is a block diagram of an embodiment of the electronics structureof an automated smart pack dispenser.

FIGS. 8-10 are schematic illustrations of an embodiment of a smart packthat changes colors or shades as the medications in the smart packapproach expiration and reach expiration.

DETAILED DESCRIPTION OF THE EMBODIMENTS

FIG. 1 is a schematic block diagram of an embodiment of a blister packsmart dispensing package 100 that is referred to herein as a “smart pack100.” As disclosed in FIG. 1, the smart pack 100 consists of a blisterpack 104 that has a plurality of indentations or blister pockets 110that are arranged and sized to carry solid medications, such as one ormore pills, gummies, etc., referred to herein as “pills.” The pills maybe prescription or non-prescription medications, supplements, or othersubstances that may be desirable to ingest on a periodic basis. Forexample, vitamin or mineral supplements can be used with the smart pack100, illustrated in FIG. 1. The blister pack 104 can be fabricated fromany standard material that meets FDA regulations for materials suitablefor use with pills including many plastics and is capable of deformationto form the blister pockets 110.

As also illustrated in FIG. 1, the blister overlay 102 has the same formand size as the blister pack 104. The blister overlay 102 may have acontact adhesive coating on a lower surface, so that when the blisteroverlay 102 is placed on the blister pack 104, it becomes secured to theblister pack 104. Other standard methods of securing the blister overlay102 to the blister pack 104 can be used, such as a UV sealing, a heatresponsive adhesive, or other adhesives. The electronics andcommunications package 122 is located over a portion of the blister pack104 that does not have blister pockets 110, such as illustrated in theembodiment shown in FIG. 2. The conductors 106 are laid out over thearea where the blister pockets 110 are disposed, as also shown in FIG.2.

Referring again to FIG. 1, the electronics and communication package 122includes a processor 108 that is connected to the conductors 106. Theprocessor 108 transmits signals periodically to the conductors 106 todetermine conductivity and thereby determine if a portion of the blisteroverlay 102 has been punctured to remove a pill disposed in a blisterpocket 110. When it is determined that there is a lack of conductivity(open circuit) of the conductors adjacent to a blister pocket 110,indicating that a pill has been removed from a blister pocket 110, thetime and date is stored in storage circuitry 120. The processor 108 thentransmits this information (referred to herein as “adherence data”) tothe communications circuitry 112, which causes the adherence data to betransmitted via antenna 114, to a local receiver. In one embodiment, amobile phone, pad computer, or other device, connects with theelectronics and communication package using a near field communication(NFC) signal when a link is established. The communications circuitry112 requests adherence data from processor 108, which then retrieves theadherence data from storage 120. The adherence data indicates whether apatient has adhered to the medication schedule that has been prescribedfor that medication. The processor 108 then transmits the adherence dataretrieved from storage 120 to the communications packet 112 and to theantenna 114. The adherence data is then received by the NFC device, orother communication device, such as a mobile phone, as explained in moredetail below. A battery 105 powers the electronics and communicatorpackage 122. A GPS receiver 107 may also be included in the electronicsand communications package 122. GPS receiver 107 is connected to antenna114 and receives satellite data, determines a physical location of thesmart pack 100 and transmits the location data to processor 108.

FIG. 2 is a schematic illustration of the smart dispensing packet 100showing the conductors 106 that are disposed on the blister overlay 102.The conductors may be deposited on the blister overlay 102 using aconductive ink, or other conductive material. As illustrated in FIG. 2,the conductors 106 are spread out in a geometric pattern, creatinggeometric pattern conductors 115 that are positioned over the puncturearea 116 of the blister overlay, so that puncture of the blister overlay102 to retrieve medication from a blister pocket 110 (FIG. 1) willresult in the geometric pattern conductor 115 being broken anddisconnected from the circuit, creating an open circuit. The lack of aconductive path for that particular row and column for the blisterpocket 110, where the open current is located, is determined by theelectronics and communication circuitry 122, and the time and day, andin some cases the location of the smart pack 100, is recorded by theelectronics and communication circuitry 122. When there is a punctureand a resultant open circuit, it is assumed that the patient puncturedthe blister overlay 102, removed, and consumed the medication. The timeand day and in some cases the location that this occurred is referred toas “adherence data” since the data indicates whether the patient hasadhered to the prescribed medication schedule. This adherence data isstored in the electronics and communication circuitry 122. The blisteroverlay 102 is made from a thin plastic material, which allows a user topuncture the blister overlay 102 to gain access to the pills stored in ablister pocket 110. The blister overlay 102 is, however, sufficientlystrong to prevent accidental puncture and disruption of the conductors106 on the blister overlay 102. Conductive ink, which forms a conductor,can be applied in several different ways. For example, conductive inkcan be screened onto the blister overlay 102, using standard off-setprinting techniques or standard screening techniques. In addition, theconductive ink can be applied with a plotter using inkjet technology.Other methods can also be used. It is important that the ink adhere wellto the blister overlay 102, so that a material should be used for theblister overlay 102 that allows for good adhesion of the conductive ink.The overlay materials may be foil materials that are coated with aninsulated plastic, a paper material, various plastics, biodegradablematerials, plant based materials that change color over time such asdisclosed herein, heat sensitive materials, UV sensitive materials,linear or bidirectional aligned molecular material or virtually anymaterial that can be printed and broken using standard finger pressure.Single or multiple layer overlay configurations consisting of either asingle or multiple materials can also be used. Printed electronics canbe used in multiple layer configurations to prevent the accidentalremoval of a conductor as a result of abrasion during handling of thesmart pack 100. The materials used should be designed to have aselective bursting pressure which allows a user to access a blisterpocket 110 using standard finger pressure. In addition, the overlay mayhave reinforced areas that are not aligned with the blister pockets 110so that the bursting pressure adjacent the blister pockets 110 is muchless than other portions of the blister overlay 102. Polypropylene andpolyethylene are two example materials that may be used for the blisteroverlay 102. The conductive ink can be made from various materialsincluding powder, liquid or plant based materials. The conductive inkcan be curable with heat, UV light or various chemical processes. Theconductive ink can also cure simply by drying. The conductive ink isflexible and has the ability to conduct when subjected to fluctuationssuch as bending of the blister overlay 102. The conductive ink can beformulated to change color or shades upon the occurrence of certainconditions. For example, the conductive ink may initially be invisibleto minimize the visual footprint of the printed electronics whileretaining the conductive functionality of the conductive ink. A colorchange or shading change may then occur to indicate a change of state orenvironmental change such as when the package contents have expired. Forexample, the conductive ink or other inks placed on the overlay canindicate that the package contents, i.e. the medications or othermaterials stored in the blister pack, have expired.

The conductors 106 may comprise geometric pattern conductors 115 such asthe zigzag geometric pattern conductors illustrated in FIG. 2. Ofcourse, any geometric pattern can be used for the geometric patternconductor 115. The conductors 106 also include the connecting conductors117 that connect the geometric pattern conductors 115 to the electronicsand communication circuitry 122. The connecting conductors 117 may belaid out in rows and columns or other layout that allows identificationof each geometric pattern conductor 115 that is broken. In other words,the connecting conductors 117 are connected to the geometric patternconductors 115 in a manner that allows each of the geometric patternconductors 115 to be individually identified as to the location of thegeometric pattern conductor 115 on the blister overlay 102 so that theblister pocket 110 that has been accessed can be identified usingconductance to identify the rows and columns of each geometric patternconductor 115, that has been broken. The use of series connectedresistive conductors to reduce the number of connecting conductors, suchas disclosed in U.S. Pat. No. 8,960,440 and U.S. patent applicationpublications US 2015/0286852, US 2015/0148947, US 2010/0089791, US2017/004284 and PCT application WO 2017/062464 does not allowidentification of individual blister pockets such as blister pocket 110.The identification of which blister pocket has been opened allowsidentification of the medication that has been accessed by the patient.In this manner, there is no confusion as to the specific blister pocketthat has been opened or number of blister pockets 110 that have beenaccessed, and the specific date and time which these blister pocketshave been accessed. As such, a clear chain of possession of each of thepills of the medication can be established.

In addition, the electronics in communication package 122 which isplaced on the blister overlay 102 is operated by battery 105. Usingresistive elements to determine which blister pocket has been accesseduses substantially more energy than simply checking the conductance ofthe conductors 106. Accordingly, the layout, such as illustrated in FIG.2 in which each geometric pattern conductor 115 can be checked forconductance because each geometric pattern conductor 115 is connected toa connecting conductor 117 is a much more efficient manner ofdetermining the location of a broken geometric pattern conductor 115compared to using resistive elements.

Furthermore, both the geometric pattern conductors 115 and theconnecting conductors 117 can be easily and inexpensively printed withconductive ink as described above. The inexpensive processes forprinting the conductive ink such as screening, ink jet printing, off-setprinting and the other techniques described as well as other inexpensivetechniques reduces the manufacturing costs of the smart dispensingpackage 100. The smart dispensing package 100 then becomes a disposablepackage that is manufactured by highly automated techniques to allowmass-production of the smart dispensing package 100. The electronics andcommunications circuitry 122 can be attached to the blister overlay 102using adhesives or other bonding materials that firmly secure theelectronics and communications circuitry 122 to the overlay 102.Automated pick-and-place robots can accurately place the electronics andcommunication circuitry 122 on the blister overlay 102. In addition, theconductors 106 can be accurately aligned with the electronics andcommunications circuitry 102 using standard edge detection techniques.Electronics and communications circuitry 122 includes an antenna 114(FIG. 1) for transmitting and receiving information on the blister packsmart dispensing package 100. The antenna can be printed usingconductive ink using the various techniques disclosed herein.

FIG. 3 is a schematic block diagram illustrating an embodiment of asystem for data transfer of data generated by the smart dispensingpackage 302. As illustrated in FIG. 3, the smart pack, or smartdispensing package 302, collects and stores adherence data, togetherwith information regarding the patient as described above. A handhelddevice, such as a cell phone, pad computer, or other device, thatincludes a communications system, links to the smart dispensing package302. When a communication link is established, the smart dispensingpackage 302 retrieves adherence data and medical identification data forthe patient from storage 120 (FIG. 1) and transmits the adherence datavia communications package 112 and antenna 114 to the handheld device304.

The handheld device 304 of FIG. 3 can comprise any device that canestablish a link to smart pack 302 and retransmit data, and does nothave to be handheld. For example, fixed communications systems may belocated at various locations, such as in homes, public buildings, malls,doctors' offices, hospitals, and other locations that can perform thesame functions as the handheld device 304 and, for purposes of thisapplication are all referred to as handheld devices. The handheld device304 may use any number of different protocols, including a near fieldcommunication protocol, Bluetooth, Wifi, various RFID protocols, zigbee,WIMAX, or other communication protocol. For ease of disclosure, all ofthese communication devices are referred to hereinafter as “handhelddevices” even if they are stationary devices.

The handheld device of FIG. 3 then retransmits the adherence data to thecloud 305. The cloud 305 consists of servers and storage for storingadherence data for each patient, which can then be accessed, via asecure password, or other security techniques such as by encryption, byauthorized individuals, such as law enforcement 308, healthcareproviders 310, pharmacies 312, or insurance companies 314. The adherencedata can be used to create a patient accountability score or adherencescore which can be used for a number of different purposes. Patientaccountability data is used to create an accountability score, orpatient accountability, that indicates how accountable a patient hasbeen in adhering to the regimen of taking the medication. Anaccountability score can be generated in various different ways. Forexample, a patient accountability score can be generated based upon thepercentage of the times which the patient has taken the medication. Asan example, if a patient is only taking the medication 50% of the time,the patient score can be 50. If the patient takes the medication 100% ofthe time, the score would be 100. The scoring entity can also modify thescore if the patient takes the medication late. In this manner, apatient accountability score can be created in accordance with thespecific information that is of importance to the entity that designsthe patient accountability score.

Law enforcement may use the adherence data and location data todetermine if there has been a misuse of a controlled substance, such asopioids. A healthcare provider 310 may use the patient accountabilityscore to determine the efficacy of the treatments to the patient and tomodify a treatment program for the patient. Pharmacies and automateddispensers may use the adherence score for automated restocking ofinventory using an automated inventory program. Insurance companies 314may set the price of health insurance based upon the patientaccountability score. Insurance companies and healthcare providers mayuse the patient accountability score to encourage the patient to morecarefully adhere to the schedule for taking medicines.

FIG. 4 is an embodiment of a distribution and data collection process400 using the various embodiments of the smart pack system illustratedin FIGS. 1 through 10. As illustrated in FIG. 4, the drug makeroriginally manufactures the drug at step 402. Currently, drugs are beingmanufactured around the world. Some drug manufacturers produce betterdrugs than others. In addition, there are a number of instances ofcounterfeit drugs being manufactured and sold on the open market. UnderU.S. law, drug manufacturers must provide data for each lot of drugs ithas manufactured, in an effort to prevent the sale of counterfeit drugsor low quality drugs. However, sometimes this data is falsified,resulting in patients receiving low quality or counterfeit medications.If this is discovered, recalls usually occur by manufacturing lot. Whenfilling prescriptions, pharmacies may fill the prescription by drawingfrom two or more lots to completely fill the prescription. As such,filled prescriptions may include pills that are mixed from differentlots. If a recall is issued for a particular lot, the entire filledprescription will have to be recalled, resulting in a waste ofmedications that may be perfectly fine, assuming that the pharmacy haseven kept records of which lots were used to fill the prescription. Thiscan be an expensive process, since some medications can be quite costly.Further, the expiration of the medications from different lots may bedifferent. The expiration date must be set for the expiration date ofthe lot which has the earliest expiration data, which can also result ina waste of medication. Further, U.S. law requires that a chain ofcustody be established from the drug manufacturer all the way to the enduser. As indicated above, pharmacies may, or may not, actually recordwhich lots of a medication were used to fill a prescription. As aresult, the chain of custody of each lot of medication is notestablished, which is a violation of U.S. drug regulations.

At step 404, of FIG. 4, the drug maker performs a spectral analysis ofeach of the lots of medications and provides the drugs and data to adrug wholesaler. If each of the pills in the blister pockets hasundergone spectral analysis, and that data is saved, a detailed recordof the strength or efficacy of the medications taken by a patient can bedetermined by a healthcare provider or other authorized individual. Thedrug wholesaler then sells the drugs by lot and the lots can bedelivered to a smart pack packager, at step 406. In order to overcomethe problems of mixing lots and detecting poor quality drugs, the smartpack packager performs its own spectral analysis of each lot andgenerates certification data. In this manner, the smart pack packagercan certify the efficacy and strength of the drugs and, from that data,can calculate expiration dates and medication strength. In this manner,falsified, or otherwise incorrect, data from a drug manufacturer isdetected and a certification is then made by the smart pack packagerregarding the efficacy of the drugs. At step 410, the blister pack smartdispensing packages are filled with pills by lot, with the certificationprovided by the smart pack packager.

Since the smart packs illustrated in FIGS. 1 and 2 can be manufacturedto hold a different number of pills, there is little waste in ensuringthat each smart pack only includes a single lot of medication. Forexample, some smart packs may only have eight or ten blister pockets,while others may have up to 50 blister pockets. Mixing and matching theblister packs for a particular medication allows the blister packpackager to effectively use medications from a single lot in eachblister pack with little or no waste.

At step 412 of FIG. 4, the smart pack packager certification data andlot number data are entered into the electronics and communicationpackage 122 together with the identifying information of the drug, andthe smart packs are then delivered to a pharmacy 312, or automateddispenser 600 (FIG. 6), at step 412. In some cases, the smart packpackager may be a pharmacy. At step 414, the pharmacy 312, or automateddispenser 600, receives the prescription from the healthcare providerfor a particular individual. A secure communication link between thehealthcare provider 310 and the automated dispenser 600 is established.In addition, secure authorization codes are also established to preventany fraud in loading a prescription into an automated dispenser.

At step 416 of FIG. 4, the pharmacy 312, or the automated dispenser 600,loads the patient information into the smart pack 100 and stores thisinformation as to the prescription, the serial number of the smart pack100, and other information, on a server/storage on the cloud. Thepharmacy 312, or automated dispenser 600, then generates a patient label506, which is placed on the box 502 (FIG. 5) containing the smart pack100.

At step 418 of FIG. 4, the pharmacy 312, or automated dispenser 600,dispenses the smart pack package 500 (FIG. 5) to the user in person, bymail, or in the case of an automated dispenser 600, at the location ofthe automated dispenser 600. At step 420, the smart pack 100 has beendistributed to the user and the electronics and communications package122 on the smart pack 100 records the time and day; and possibly thelocation, of opening of the smart pack 100 for each pill in the smartpack 100. At step 422, a handheld electronic device, such as a mobilephone, pad computer, or other communication device, that includes acommunications package, such as near field, communications, Bluetooth,or other communication protocol, as described in more detail above,communicates with the electronics and communication circuitry 122 on thesmart pack 100 and transfers data stored in the electronics andcommunication package 122 to designated servers and storage on thecloud. The handheld electronic device, or other device, transfers theinformation to the cloud when it is connected by Wifi, or otherconnection, to the cloud. At step 424, a data structure is established,which indicates adherence of the patient to a medication schedule. Atstep 426, the adherence data is used by insurance companies to set ratesand for other uses. At step 428, the data structure is analyzed andalarm messages can be sent to third parties, including healthcareprofessionals, if a patient has not taken needed medication within acertain period.

FIG. 5 is a schematic illustration of the smart pack package 500 for thesmart pack system. As illustrated in FIG. 5, smart pack package 500includes a box 502 having a prelabel 504. The prelabel has all of theidentifying information for the medication included in the blister packsmart dispensing package 100. In the example shown in FIG. 5, themedication is 20 mg tablets of Lisinopril, a blood pressure medicine,which is shown at the top of the prelabel 504. The prelabel alsoincludes a bar code, which identifies the medication and a serial numberthat is associated with the blister pack smart dispensing package 100.The box 502 also includes a patient label 506. Prior to dispensing thepackage illustrated in FIG. 5, the pharmacy, or automated dispensingdevice, prints a patient label 506 that identifies the patient andprovides instructions on how to take the medication. The automated smartpack dispenser 600, illustrated in FIG. 6, is capable of printing apatient label 506 from the information provided to the automateddispenser 600 by the healthcare provider 310. In addition, the pharmacy312, or automated smart pack dispenser 600 (FIG. 6) loads the patientdata into the blister pack smart dispensing package 100 using theelectronics and communication package 122 disposed on the blister packsmart dispensing package 100. Again, the electronics and communicationspackage 122 may use near field communication techniques or othercommunication protocols to transmit and receive patient information. Awireless communication system can be used by the pharmacy 312, or anautomated smart pack dispenser 600, to load the patient data into theblister pack smart dispensing package 100.

FIG. 6 is a schematic illustration of an embodiment of an automatedsmart pack dispenser 600. The automated smart pack dispenser 600 has asecure communications link to either a pharmacy 312 or healthcareprovider 310, so that either a pharmacy 312 or healthcare provider 310can provide patient prescription information to the automated smart packdispenser 600. For example, the automated smart pack dispenser 600 maybe connected via a secure T1 line to a central office and may send andreceive secure communications that are encrypted. In another embodiment,the automated smart pack dispenser 600 may have a Wifi or wired Internetconnection, such as Wifi unit 610, or wired Internet connection 608 andencrypted data can be communicated over the Internet. The automatedsmart pack dispenser 600 can therefore receive prescription data anddispense prescriptions automatically to authorized individuals. Highlycontrolled prescriptions, such as opioids, can also be dispensed throughthe automated smart pack dispenser 600, through the use of a biometricdetector 612. The biometric detector 612 includes a sensor for sensingbiometric information regarding the patient, such as fingerprints, irisdetection, retinal detection, or other biometric information. Forexample, facial recognition may be used and compared to a stored pictureof a patient. Typical iris or retinal detectors require the user tostare into the detector to identify the patient as a result of theunique character of the iris or retina. Of course, the biometric datamust be transmitted to the automated smart pack dispenser 600 from ahealthcare provider, or other source, so that the automated smart packdispenser 600 can compare the detected biometric data with the storedbiometric data. Government IDs can also be used to identify a patient.

The automated smart pack dispenser 600 of FIG. 6 contains the packagesof medications such as box 502, as illustrated in FIG. 5, which containsthe blister pack smart dispensing package 100 that includes theelectronics and communications package 122, the prelabel 504 and thepatient label 506. When a prescription is received by the automatedsmart pack dispenser 600, the patient is prompted to insert a credit ordebit card in the card reader 606, to authorize the transaction.Communication electronics 706 (FIG. 7) disposed within the automatedsmart pack dispenser 600, of FIG. 6, then generates an encryptedwireless signal that is directed to a specific blister pack smartdispensing package 100, located in the automated dispenser 600. In otherwords, the signal generated by the communication electronics 706 isencoded for a specific box of medication contained in the automateddispenser 600 so that the electronics and communication package 122(FIG. 5) for that specific box of medication can be programmed with theprescription information for the patient purchasing the medication. Thesmart pack 100 is then programmed with the prescription information forthat patient. Simultaneously, a labeler 716 (FIG. 7) generates a patientlabel 506 (FIG. 5), which is placed on the box 502 (FIG. 5) for thedesignated blister pack smart dispensing package 100 that has beendesignated for that patient in the automated smart pack dispenser 600.That package is then dispensed through dispenser 602 to the patient. Ifthe prescription is a controlled medicine, such as an opioid, thepatient must identify themselves by using the biometric detector 612prior to dispensing the package to the patient.

FIG. 7 is a schematic block diagram of various electronic components ofthe automated smart pack dispenser 700. As illustrated in FIG. 7, aprocessor 702 is programmed to control the various componentsillustrated in FIG. 7. Communications electronics 706 receives securetransmissions from a pharmacy or healthcare provider relating toprescriptions to be dispensed by the automated smart pack dispenser 700.The prescription data is then forwarded to the processor 702, whichstores the prescription data and generates information regarding thepatient and the prescription to be dispensed, which is displayed ondisplay screen 604. The processor then displays a message on the displayscreen 604 to have the user of the automated smart pack dispenser 700insert a debit or credit card into the card reader 606. A government IDcan also be read by card reader 606 to identify the user of theautomated dispenser 600. The processor transmits the card informationvia the communication electronics 706 via the Internet, or a secured T1line, to a bank or card company for authorization. Authorization data isthen received from the bank or card company via the communicationelectronics 706. The processor 702 then generates information for thepatient label 506 (FIG. 5) from the patient data in the storage 704. Ifthe prescription calls for a controlled medication, such as an opioid,the processor 702 generates a signal for the display screen 604 thatinstructs the user to use the biometric reader 612. For example, apatient may be directed to look into the biometric reader 612 to obtainan iris or retinal scan. In another embodiment, a patient may be askedto place a finger, or a hand, on a fingerprint or hand reader forverification. Of course, if the prescription is not a controlledmedication, such as an opioid, a biometric reader is not required, sinceany authorized adult can sign for the medication. Once the payment hasbeen authorized and the patient label 506 has been applied to box 502(FIG. 5), the dispenser 714 dispenses the box 502.

FIG. 8 is a schematic illustration of the blister overlay 102. Theblister overlay 102, as illustrated in FIG. 8, contains compounds thatage over time. These compounds are plant based material that changecolor or shading over time. The color and shading is based uponoxidation of these plant based materials that change color and shade asa result of oxidation. The blister overlay 102 is manufactured to changecolor or shading over a specific time period. The blister overlay 102,illustrated in FIG. 8, is a newly manufactured overlay that is clear.The time period over which the color change occurs in the blisteroverlay 102, corresponds to the expiration date of the medicationenclosed in the smart pack 100 which can include drugs, supplements,pharmaceuticals, nutraceuticals, orals, solids, liquids, powders andgels, as set forth above. Orders are dispensed by pharmacies andautomated dispensers based upon color change tables which have acorresponding expiration date for the contained contents. Thisinformation is also loaded into the electronics and communicationpackage 122 and stored in the storage 120, as illustrated in FIG. 1. Assuch, the color or shade change that occurs in the blister overlay 102is time based and duration specific. The color or shade change is tiedto the drug expiration date so that blister overlays 102 are matchedwith specific lots of drugs that have a corresponding expiration date.In this manner, the potency and strength and the correspondingexpiration date can be matched with the proper blister overlay 102 sothat the color change or shading is a visual indication of the potencyor viability of the drug. Of course, inhibitors can be used whichinhibit the process of color and shade change to slow the process ofcolor and shade change. Further, accelerators can be added to theprocess to speed up the color and shade changing process. Some of theseinhibitors and accelerants use processes for changing the oxidation rateof the materials that cause the color and shade change. In some cases,the price of the contents of the smart pack 100 can be adjusted and theprice can be based upon the potency of the contents of the smart pack100. In that regard, the price may be reduced for a drug that is lesspotent. For example, it is known that antibiotics lose potency overtime. After several years, the potency may be reduced by a percentage ofthe original potency. Although the drug is still effective at a reducedpotency, the entity selling the drug may wish to reduce the price. Thecolor change and shading can be automatically detected usingphotoelectric devices, optical sensors, CCD arrays, photographictechniques, and other light sensing techniques. These detected values ofcolor and shade changes can then be stored in the electronics andcommunication package 122 in storage 120. In this manner, the smart pack100 can communicate information relating to potency of the contents ofthe smart pack 100 and the status of the color/shade change withoutphysically inspecting the package. The stored data can provideinformation as to whether or not the contents of the smart pack 100 canbe used. For certain products, not only does the efficacy of the productchange, but some products should not be used after an expiration date.If a product is determined to be in an unsafe range, notifications andcertain protocols can be used to contact the user and the properauthorities to confiscate and destroy the product. These communicationprotocols can be either automatic or manually performed by properauthorities.

As also illustrated in FIG. 8, in the process of manufacturing theblister overlay 102, the electronics package 122 is deposited, or placedby various methods, on the blister overlay 102. In one embodiment, asilicone substrate can be bonded directly onto the blister overlay 102.Conductive ink can be used to connect the various components and createthe conductors 106 (FIG. 1), as illustrated in FIG. 2.

FIG. 9 is a schematic illustration of the blister overlay 102 that hasbecome shaded or has changed colors as a result of the expiration of acertain time period. In other words, the blister overlay 102 begins tochange colors, as illustrated in FIG. 9, after a period of time,indicating that the expiration period for the medications in the smartpack is approaching. When the blister overlay 102 is manufactured, thecombination of compounds used in the blister overlay determines the timewhen the blister overlay 102 starts to change colors, or becomes shaded.The blister overlay is matched with the expiration date of a particularlot of medications that has an expiration date corresponding to when theblister overlay 102 changes colors. The blister overlay 102 is then usedwith a blister pack 104 (FIG. 1) containing pills that have a matchingexpiration date.

FIG. 10 is an illustration of a blister overlay 102 that has changed tobe heavily shaded, opaque, or heavily colored, indicating that themedication contained within the blister pack 104 has expired. In thismanner, there is a clear indication to the user that the medicationcontained within the smart pack having the blister overlay 102 haseither a diminished efficacy or may be dangerous to take.

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed, andother modifications and variations may be possible in light of the aboveteachings. The embodiment was chosen and described in order to bestexplain the principles of the invention and its practical application tothereby enable others skilled in the art to best utilize the inventionin various embodiments and various modifications as are suited to theparticular use contemplated. It is intended that the appended claims beconstrued to include other alternative embodiments of the inventionexcept insofar as limited by the prior art.

1-35. (canceled)
 36. An apparatus comprising: an overlay configured foroperative attachment to a blister pack, the blister pack configured todispense medication from each of a plurality of blister pocketsconfigured to contain the medication, the overlay comprising: geometricpattern conductors disposed on the overlay and aligned with each of theplurality of blister pockets when the overlay is operatively attached tothe blister pack so that at least a portion of the geometric patternconductors are broken when the medication is removed from one of theplurality of blister pockets creating an open circuit in the geometricpattern conductors, a plurality of connecting conductors disposed on theoverlay that are electrically coupled to the geometric patternconductors and configured to detect the open circuit in the geometricpattern conductors and identify the geometric pattern conductors thathave been broken, and processing and storage circuitry disposed on theoverlay configured to detect the open circuit and store a time when theopen circuit is detected, to create adherence data.
 37. The apparatus ofclaim 36, further comprising: communication circuitry disposed on theoverlay and electrically coupled to the processing and storage circuitryand configured to communicate the adherence data to a server accessibleto authorized individuals.
 38. The apparatus of claim 37, wherein theplurality of connecting conductors are formed from conductive ink. 39.The apparatus of claim 38, wherein the geometric pattern conductors havea zigzag geometric pattern over each of the plurality blister pockets.40. The apparatus of claim 38, wherein the plurality of connectingconductors are configured in columns and rows to individually identifygeometric pattern conductors that have been broken.
 41. The apparatus ofclaim 36, wherein the medication is a solid medication, a jellmedication, or a liquid medication.
 42. The apparatus of claim 36,further comprising an automated dispenser configured to dispense theblister pack, the automated dispenser comprising: communicationelectronics disposed in the automated dispenser that receivesprescriptions for the medication and receives data identifying themedication from the processing and storage circuitry and thecommunication circuitry of the overlay; and a processor configured togenerate control signals that control: a card reader that reads debitand credit cards, a display screen to prompt the user, a labeler thatgenerates a label containing information identifying a patient takingthe medication and instructions for taking the medication, and adispenser that dispenses the medication.
 43. The apparatus of claim 42,wherein the automated dispenser further comprises a biometric reader foridentifying the user of the automated dispenser.
 44. The apparatus ofclaim 36, further comprising a communication system operable with theoverlay and configured to communicate adherence data, indicatingadherence by a patient to a medication schedule, the communicationsystem comprising a communicator, communicably coupled to the processingand storage circuitry and configured to receive the adherence data fromthe processing and storage circuitry and transmit the adherence data toa network for storage and access by authorized individuals.
 45. Theapparatus of claim 44, wherein the authorized individuals comprise aninsurance company that generates patient accountability data to scorepatients, or a pharmacy that generates patient accountability data toscore patients, or a healthcare provider that generates patientaccountability data to score patients, or law enforcement.
 46. Theapparatus of claim 44, wherein the communicator is communicably coupledto the processing and storage circuitry via a near field communicationprotocol.